Adjustable filling and sealing apparatus

ABSTRACT

An assembly includes a support and drive assembly, a first structure and a second structure. The first structure is in operable communication with and supported by the support and drive assembly. The first structure includes at least one needle assembly and is adjustable to receive a plurality of needle assemblies. The second structure is supported by the support and drive assembly. The second structure includes at least one seal assembly and is adjustable to receive a plurality of seal assemblies. A method includes determining a number of vials that are to be filled concurrently and adjusting an assembly to include at least one needle assembly and at least one seal assembly. A number of the needle assemblies and the seal assemblies equals the number of vials.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application is a continuation of U.S. application Ser. No.10/983,178 filed Nov. 5, 2004, now U.S. Pat. No. 7,628,184, which claimsthe benefit of U.S. Provisional Patent Application Ser. No. 60/518,267,filed Nov. 7, 2003, and U.S. Provisional patent Application Ser. No.60/518,685, filed Nov. 10, 2003, all of which are hereby expresslyincorporated by reference as part of the present disclosure.

TECHNICAL FIELD

The present invention relates to methods and apparatus for use infilling vials or other containers with medicaments or other substancesby temporary introduction of a needle or syringe through a resealablecap or stopper and/or sealing such vials or containers subsequent tofilling.

BACKGROUND OF THE INVENTION

Medicaments such as vaccines are often stored in vials prior to use. Atypical vial dispenser includes a body defining a storage chamber, afill opening in fluid communication with the body, and a stopper or capfor sealing the fill opening after filling the storage chamber tohermetically seal the medicament within the dispenser. In order to fillsuch dispensers with a sterile fluid or other substance, such as amedicament, it is necessary to sterilize the unassembled components ofthe dispenser, such as by autoclaving the components and/or exposing thecomponents to gamma radiation. The sterilized components then must befilled and assembled in an aseptic isolator of a sterile fillingmachine. In some cases, the sterilized components are contained withinmultiple sealed bags or other sterile enclosures for transportation tothe sterile filling machine. In other cases, the sterilization equipmentis located at the entry to the sterile filling machine. In a fillingmachine of this type, every component is transferred sterile into theisolator, the storage chamber of the vial is filled with the fluid orother substance, the sterilized stopper is assembled to the vial to plugthe fill opening and hermetically seal the fluid or other substance inthe vial, and then a crimping ring is assembled to the vial to securethe stopper thereto.

One issue associated with such dispensers, and processes and equipmentfor filling such dispensers, is that the filling process is timeconsuming, and the processes and equipment are expensive. Further, therelatively complex nature of the filling processes and equipment canlead to more defectively filled dispensers than otherwise desired. Forexample, typically there are at least as many sources of failure asthere are components. In many cases, there are complex assembly machinesfor assembling the vials or other dispensers that are located within theaseptic area of the filling machine that must be maintained sterile.This type of machinery can be a significant source of unwantedparticles. Further, such isolators are required to maintain sterile airwithin the barrier enclosure. In closed barrier systems, convection flowis inevitable and thus laminar flow, or substantially laminar flow,cannot be achieved. When operation of an isolator is stopped, a mediafill test may have to be performed which can last for several, if notmany days, and can lead to repeated interruptions and significantreductions in production output for the pharmaceutical or other productmanufacturer that is using the equipment. In order to address suchproduction issues, government-imposed regulations are becomingincreasingly sophisticated and are further increasing the cost ofalready-expensive isolators and like filling equipment. On the otherhand, governmental price controls for injectables and vaccines,including, for example, preventative medicines, discourage such majorfinancial investments. Accordingly, there is a concern that fewercompanies will be able to afford such increasing levels of investment insterile filling machines, thus further reducing competition in theinjectable and vaccine marketplaces.

SUMMARY OF THE INVENTION

Exemplary embodiments of the invention include an assembly that includesa support and drive assembly, a first structure and a second structure.The first structure is in operable communication with and supported bythe support and drive assembly. The first structure includes at leastone needle assembly and is adjustable to receive a plurality of needleassemblies. The second structure is supported by the support and driveassembly. The second structure includes at least one seal assembly andis adjustable to receive a plurality of seal assemblies.

Exemplary embodiments of the invention further include a method thatincludes determining a number of vials that are to be filledconcurrently and adjusting an assembly to include at least one needleassembly and at least one seal assembly. A number of the needleassemblies and the seal assemblies equals the number of vials.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a needle filling andlaser sealing assembly, a vial or other container to be filled andsealed, and schematic representations of a laser beam provided by theassembly and radiation sensed by the assembly;

FIG. 2 is a side elevational view of the assembly and vial of FIG. 1,with the needle manifold in a position whereby the needle is insertedinto the vial and illustrating the substantially laminar flow of asepticair laterally over the vials and/or other containers being filled and/orre-sealed;

FIG. 3 is a top elevational view of the assembly of FIG. 1;

FIG. 4 is another side elevational view of the assembly of FIG. 1,without the vial or container;

FIG. 5 is a perspective view of the assembly of FIG. 1, without the vialor container;

FIG. 6 is another perspective view of the assembly of FIG. 1;

FIG. 7 is a back elevational view of the assembly of FIG. 1;

FIG. 8 is a side elevational view of the assembly of FIG. 1, with theneedle manifold removed therefrom;

FIG. 9 is a top elevational view of the assembly of FIG. 1 with theneedle manifold removed therefrom;

FIG. 10 is a perspective view of the assembly of FIG. 1 with the needlemanifold removed therefrom;

FIG. 11 is a perspective view of the assembly of FIG. 1 with the needlemanifold removed therefrom;

FIG. 12 is a front elevational view of the assembly of FIG. 1 and acover installed on the needle manifold;

FIG. 13 is a side elevational view of the assembly of FIG. 1 and a coverinstalled on the needle manifold;

FIG. 14 is a perspective view of the assembly of FIG. 1 and the cover ofFIG. 13;

FIG. 15 is a side elevational view of the needle manifold with a coverremovably connected thereto;

FIG. 16 is a side elevational view of the needle manifold with thecover;

FIG. 17 is a perspective view of the needle manifold with the cover;

FIG. 18 is a top elevational view of the needle manifold;

FIG. 19 is a side elevational view of the needle manifold without thecover;

FIG. 20 is a side elevational view of the needle manifold;

FIG. 21 is a perspective view of the needle manifold;

FIG. 22 is an elevational view of a needle assembly of FIG. 1;

FIG. 23 is a cross-sectional view of the needle assembly of FIG. 22along line 30-30;

FIG. 24 is a side elevational view of a seal and sense assembly of theassembly of FIG. 1;

FIG. 25 is a front elevational view of the seal and sense assembly ofFIG. 24;

FIG. 26 is a side elevational view of the assembly of FIG. 1 with theneedle manifold removed and after adjustment of the sealing and sensingmanifold and addition of three additional sealing and sensingassemblies;

FIG. 27 is a perspective view of the assembly of FIG. 26;

FIG. 28 is a side elevational view of the needle manifold afteradjustment and addition of three additional needle assemblies;

FIG. 29 is a perspective view of the assembly of FIG. 26 and the needlemanifold as shown in FIG. 26; and

FIG. 30 is a perspective view of the assembly of FIG. 29.

DETAILED DESCRIPTION

Referring to FIGS. 1-7, an assembly 100 is illustrated. The assembly 100is used in filling a vial 102 or other container with medicaments orother substances by temporary introduction of a needle 104 or syringethrough a resealable cap or stopper 106 and sealing such vials orcontainers after such filling. The assembly 100 may be used, forexample, in association with a conveyor system(s) that transports thevials or containers to/from the assembly and/or an enclosure to helpprevent contaminants from reaching the assembly and/or vials orcontainers.

In addition, the assembly and/or methods described herein may be used,for example, in apparatus and/or methods disclosed in U.S. Pat. No.6,604,561, which issued Aug. 12, 2003 entitled, “MEDICAMENT VIAL HAVINGA HEAT-SEALABLE CAP, AND APPARATUS AND METHOD FOR FILLING THE VIAL”,U.S. patent application Ser. No. 10/655,455, filed Sep. 3, 2003entitled, “SEALED CONTAINERS AND METHODS OF MAKING AND FILLING SAME”,U.S. patent application Ser. No. 10/766,172, filed on Jan. 28, 2004entitled, “MEDICAMENT VIAL HAVING A HEAT-SEALABLE CAP, AND APPARATUS ANDMETHOD FOR FILLING THE VIAL”, U.S. patent application Ser. No.10/600,525, filed Jun. 19, 2003 entitled, “STERILE FILLING MACHINEHAVING NEEDLE FILLING STATION WITHIN E-BEAM CHAMBER”, and U.S. PatentApplication Ser. No. 60/550,805, filed Mar. 5, 2004 entitled, “APPARATUSFOR NEEDLE FILLING AND LASER RESEALING, each of which is herebyexpressly incorporated by reference as part of the present disclosure.The assembly and/or methods described herein, may also use one or moreportions of the apparatus and/or methods disclosed in one or more ofsuch applications. Furthermore, it should be recognized that one or moreportions of the assembly and/or methods described herein may be used inassociation with one or more portions of the apparatus and/or methodsdisclosed in such applications.

The assembly 100 includes a first structure, which is referred tohereinafter as the needle manifold 110, and a support and drive assembly114. The assembly 100 may also include a second structure, which isreferred to hereinafter as the seal and sense unit manifold 112. Theseal and sense unit manifold 112 is utilized if the user desires to sealthe needle penetration area and sense that the seal is proper in thesame assembly. Note that schematic representations of a laser beam 116provided by the seal and sense unit manifold 112 and radiation 118sensed by the seal and sense unit are also shown as dashed linesthroughout the drawings.

The needle manifold 110 includes one or more needle assemblies 120 (onlyone being shown in FIG. 1) and one or more support assemblies 122. Asshown in FIG. 28, if more than one needle assembly 120 is employed, theneedle assemblies (shown as 120A, 120B, 120C, and 120D) are, forexample, arranged linearly and adjacent to one another (side by side) atrespective positions in the manifold 110. Each needle assembly 120includes the needle 104 and a needle support 124. The needles 104 areused to deliver medicament or other substance(s) into vials or othercontainers. In order to accommodate multiple needle assemblies 120, theneedle manifold 110 is adjustable in that needle assemblies 120 can beadded to and/or removed from the manifold 110 in order to provide aspecific number of needles 104 desired in a particular application.

Referring again to FIGS. 1-7, each of the needles 104 has a port in flowcommunication with one or more sources of medicament or other substances(not shown). This flow communication may be provided, for example, byflexible tubes (not shown). Providing multiple needles makes it possibleto fill multiple containers concurrently, if desired. As can be seen,each needle 104 is preferably a non-coring needle.

The support assemblies 122 are shown disposed at opposite ends of theneedle manifold 110 on opposite sides of the needle assembly(s) 120.Each support assembly 122 includes a stopper portion 130. The needlemanifold 110 is removable from the assembly, so as to enable the needlemanifold 110 to undergo maintenance, cleaning, sterilization, and/orrepair or replacement. FIGS. 8-11 illustrate the assembly 100 with theneedle manifold removed. As will be further described below, the needlemanifold 110 and the support and drive assembly 114 are provided withcomplementary catches that engage one another to releasably retain theneedle manifold 110 to the support and drive assembly 114.

The seal and sense unit manifold 112 includes one or more seal and senseassemblies 140 (only one being shown in FIG. 1). As shown in FIGS. 26and 27, if the manifold 112 has more than one assembly 140, the seal andsense assemblies (shown as 140A, 140B, 140C, and 140D) are, for example,arranged linearly and adjacent to one another at respective positions inthe seal and sense unit manifold 112. Each seal and sense assembly 140may include, for example, a laser optic source assembly 142, an infrared(“IR”) sensor 144, and a support portion 146. Each laser optic assembly142 is adapted to provide the laser beam 116 to reseal a resealable capor stopper 106 on the vial 102 after the vial 102 has been filled byneedle 104. It is understood that the needle 104 penetrates the stopper106 in order to fill the vial 102. The laser beam reseals thepenetration area on the stopper 106. Each of the laser optic assemblies142 may include a laser source or may be connected, for example, to arespective fiber optic cable (not shown) that connects the respectivelaser optic assembly to a respective laser source. Providing multiplelaser optic assemblies 142 makes it possible to reseal multiple vials orcontainers concurrently.

While the seal and sense manifold 112 (or second structure) and the sealand sense assembly 140 are discussed throughout this application asbeing one unit, it is understood the seal assembly and the senseassembly may be two separate units and that the manifold 112 may includeonly one of those assemblies. In addition, assembly 100 may have only aseal assembly, which would seal the penetration area created by theneedle. In an exemplary embodiment, the seal assembly is the laser opticsource assembly 142 and the sense assembly is the IR sensors 144, whichare illustrated in the figures.

The IR sensors 144 may be used, for example, to detect the temperatureof the needle penetration region during resealing, and therefore can beused to determine whether the cap or stopper 106 (FIG. 1) wassufficiently reheated to achieve resealing. Each of the IR sensors 144includes, or is connected to, a respective IR sensor module (not shown).Providing multiple IR sensors 144 enables sensing the temperature ofmultiple vials or containers concurrently, for example, as they arebeing resealed or immediately thereafter.

As with the needle manifold 110 (FIG. 28), the sealing and sensing unitmanifold 112 is adjustable in that sealing and sensing assemblies 140can be added to, and/or removed from, the manifold in order to provide aspecific number of sealing and sensing assemblies desired in aparticular application. In some embodiments, the manifold 112 also maybe provided with a removable cover to protect the assemblies, e.g.,during transport.

Referring to FIGS. 1-11, the support and drive assembly 114 is adaptedto drivingly support the needle manifold 110 and also to support theseal and sense manifold 112. This assembly 114 may include, for example,a pair of generally L-shaped stands 150, each having a base 152 andsupport column 154 extending therefrom. Each base has a drive shaft 156extending therefrom, that is drivingly connected to a drive unit, e.g.,a stepper motor (not shown) that has a lead screw drivingly coupled to abase plate (not shown) and is mounted, for example, within the base orbeneath a base plate (not shown) supporting the assembly 100.

The support and drive assembly 114 further includes a brace 160 fixedlysecured at opposite ends to a pair of laterally-extending support arms168. Each support arm 168 is fixedly secured to the upper end of arespective drive shaft 156 and is vertically movable therewith. Theassembly 114 further includes a pair of thumb screws 162, and each thumbscrew includes a head portion 164 and a rod portion 166. Each rodportion 166 extends through one end of the brace 160 and respectivesupport arm 168. The free end of each rod portion 166, which is theopposite end from thumb screw 162, threadedly engages a respectivethreaded hole 169 formed in a respective support 130 of the needlemanifold 110 to releasably retain the needle manifold 110 to the supportand drive assembly 114. It should be understood that other types ofreleasable connectors may be employed, including but not limited to,fasteners (e.g., bolts), clamps, etc.

Referring to FIGS. 1-11 and 18-21, each support arm 168 defines on itsfree end an approximately u-shaped recess 172 for receiving therein acomplementary shaped, laterally-extending flange 174 formed on therespective support portion 130 of the needle manifold 110. Thus, inorder to assemble the needle manifold 110 to the support arms 168, theuser grips the laterally-extending flanges 174 of the manifold 110 andlowers the flanges into the respective u-shaped recesses 172 of thesupport arms. Then, the user pushes the thumb screws 162 forwardly suchthat the threaded ends of the rod portions 166 are received within therespective threaded holes 169 of the support portions 130. The user thensimply turns the head portions 164 of the thumb screws to fixedly securethe manifold to the support arms.

One advantage of the illustrated embodiment of the present invention isthat the user may be located on the opposite side of the station 100relative to the vials or containers 102 (or the location for fillingand/or re-sealing the containers). In addition, since the user need onlygrip the laterally-extending flanges 174 of the needle manifold 120 toinstall the manifold, the user's hands will not extend over the locationat which the vials or other containers are filled and/or resealed (i.e.,the user need not break the needle plane), but rather will be located tothe sides of this area. Accordingly, this design further prevents thepossibility that the needle filling and/or laser re-sealing locationmight become contaminated during removal or installation of the needlemanifold.

Another advantage of the illustrated embodiment is that the needlefilling and laser sealing station 100 can be mounted within a sterileenclosure that includes glove ports for allowing an operator's hands toaccess the interior of the enclosure therethrough. Further, a user caneasily remove and install the needle manifold by employing such gloveports or other means for accessing the interior of a sterile enclosure.As indicated above, the user need only manipulate the thumb screws toremove and install the needle manifold.

In addition, the filling, sealing and sensing assembly 100 may beprovided with laminar flow 170 (FIG. 2) as part of the overall systemfor helping reduce the possibility of contamination. In this embodiment,the laminar airflow is substantially horizontal or substantiallyparallel to the base plate of the assembly.

Referring FIGS. 12-14, needle 104 is illustrated with a cover 134.Because the needles 104 preferably define non-coring, sharp tips 132that are capable of causing injury and/or becoming damaged duringremoval, transport, or installation of the manifold onto, or off of theassembly, the manifold 110 may be adapted to receive the cover 134 thatlimits or prevents access to the needles during certain times. As willbe further described below, the manifold 110 and cover 134 each may beprovided with complementary catches that engage one another toreleasably retain the cover to the manifold. In this embodiment, forexample, the needle manifold 110 defines one or more grooves 136, andthe cover 134 defines one or more flanges 138 that are removablyreceived by the groove(s) to retain the cover to the manifold at desiredtimes.

Referring to FIGS. 12-17, the cover 134 includes a laterally-extendinghandle 196 that extends approximately perpendicular to the axis or axesof the needle(s) 104. The cover 134 further defines an elongated slot198 extending from one end of the cover to the other for receivingwithin the housing the needles 104. As indicated by the arrow 200, thecover 134 is removed by gripping the handle 196 and pulling the coverlaterally in the direction of the arrow 200. In doing so, the flanges138 of the cover 134 slidably move through the grooves 136 of themanifold until the cover is released therefrom. The open end of thecover defined by the slot 198 located opposite the handle 196 allows thecover to be slipped away from the needles.

One of the advantages of the cover 134 is that it allows a user tosafely handle the needle manifold during sterilization, installationand/or removal. Preferably, the cover and components of the needlemanifold are made of suitable materials to allow gamma or othersterilization thereof prior to installation in the station 100. Ifdesired, and as indicated in broken lines in FIG. 18, the base of theslot 198 may define a recess or receptacle 202 for receiving fluid, suchas the medicament or other substance to be pumped through the needles104 and into the containers. After the needle manifold 110 is installed,and the fill tubes (not shown) are connected to the inlets 184 of theneedles 104, it is typically necessary to purge any air from the filltubes and needles prior to filling the vials or other containers. Duringthe purging process, it may be necessary to release the medicament orother substance through the needles to ensure that the needles and linesconnected thereto are substantially airless. The cover 134 andreceptacle 202 thereof may be used during the purging process to collectany such fluid or other substance released from the needles. Then, thecover may be removed and the collected fluid or other substancediscarded.

Referring to FIG. 12, the support and drive assembly 114 may be mountedon a base plate or other support 186 defining laterally-spaced apertures188 for receiving therethrough the drives shafts 156. As indicated inbroken lines, the support 188 may define any desired number ofadditional apertures 188′ to accommodate different configurations of theneedle manifold, and thereby allow the stands 150 to be located wherenecessary to accommodate the different configurations of the needlemanifold. Alternatively, the support 186 may define one or moreelongated slots rather than discrete apertures 188 to thereby allow theshafts to be moved laterally therethrough to accommodate the differentneedle manifold configurations.

Referring to FIGS. 22 and 23, the support 124 of each needle assembly120 defines a pair of substantially parallel apertures 176 extendingthrough the support and oriented approximately perpendicular to the axisof the respective needle 104. A pair of needle shafts 178 are receivedthrough the respective apertures 176 and extend outwardly on oppositesides of the support 124. As shown typically in FIG. 20, the ends of theshafts 178 are press fit or otherwise fixedly received withincorresponding apertures 180 formed in the end supports 122 of themanifold to assemble the needle assembly 120 to the end supports 122. Inthe multi-needle assembly embodiment of FIG. 28, the shafts 178 (FIG.23) are sufficiently long to mount the desired number of needleassemblies between the end supports 122 of the needle manifold.

Referring again to FIGS. 22 and 23, each needle support 124 definesopposing grooves 136, and each end support 122 likewise defines opposinggrooves 136 that are aligned with the grooves of the needle assembliesto create continuous grooves 136 in the assembled needle manifold. Theneedle support 124 defines an aperture 182, and the input end 184 of therespective needle 104 extends into the aperture 182. The input end 184of the needle 104 is spaced inwardly relative to the wall of theaperture 182 to allow an inlet tube (not shown) to be secured to theneedle inlet and fit therebetween. If desired, the needle support 124may be made of two parts 124A, 124B that are secured together by one ormore fasteners (not shown) to clamp, or otherwise fixedly secure therespective needle 104 therebetween.

Another advantage of the illustrated embodiments of the presentinvention is that the number of needles 104 and/or needle assemblies 120mounted on the needle manifold easily may be adjusted by simplyadjusting the lengths of the needle shafts 178. Thus, a user maymaintain any desired number of needle assemblies 120, and associatedneedle shafts 178 and braces 160, to accommodate the different desiredmanifold configurations.

Referring to FIGS. 24 and 25, the support 124 of each seal and senseassembly 140 defines a pair of substantially parallel apertures 190extending through the support and oriented approximately perpendicularto the axes of the drive shafts 156 (FIG. 1). A pair of mounting shafts192 are received through the respective apertures 190 and extendoutwardly on opposite sides of the support 146. The ends of the shafts192 are press fit or otherwise fixedly received within correspondingapertures 194 formed in the end support columns 154 to assemble the sealand sense assembly to the columns. In the multi-sensor and multi-needleassembly embodiment of Referring to FIG. 27, the shafts 192 aresufficiently long to mount the desired number of seal and senseassemblies between the end columns 154.

Referring to FIGS. 29 and 30, another advantage of the illustratedembodiments of the present invention is that the user may include anydesired number of seal and sense assemblies to accommodate any desirednumber of needle manifolds. Thus, a user may maintain, in addition toany desired number of needle manifolds, braces and needle shafts asdescribed above, and an associated number of seal and sense assembliesand associated mounting shafts. Thus, the stations of the currentlypreferred embodiments of the present invention easily lend themselves tobeing adjusted by users in the manner indicated, or alternatively, tobeing manufactured in different single or multi-needle, and/or single ormulti-sense and seal assembly, configurations.

Although each needle assembly 120 shown above has only one needle, theneedle assemblies are not limited to one needle. For example, in someother embodiments, one or more of the needle assemblies 120 may have twoor more needles. Although the needle assemblies 120 are shown arrangedlinearly and adjacent one another, this is not required. The supportassemblies 122 need not be disposed at the ends of the needle manifold.For example, in some embodiments, one or more support assemblies may bedisposed between one or more needle assemblies.

It should be understood that the needle manifold 110 may be used withoutthe sealing and sensing manifold 112. Thus, one aspect of the presentdisclosure is an apparatus for use in association with a fillingstation, where the apparatus comprises a manifold having two stoppers,spaced apart from one another, for capturing at least one needleassembly therebetween, at least one of the stoppers being movablerelative to the other to change the size of the spacing therebetween toallow a change in the number of needle assemblies captured therebetween.

Similarly, the sealing and sensing manifold may be used without theneedle manifold. Moreover, it should be understood that the sealing orsensing portion of the sealing and sensing manifold may be employedwithout the other, to provide a sealing manifold and/or a sensingmanifold. Alternatively, the sealing and sensing manifold may be locateddownstream of the needle manifold.

In addition, it should be understood that an adjustable needle manifoldmay be employed without a cover. Further, it should also be understoodthat the cover may be employed on a non-adjustable manifold.

Thus, while there have been shown and described various embodiments, itwill be understood by those skilled in the art that the presentinvention is not limited to such embodiments, which have been presentedby way of example only, and that various changes and modifications maybe made without departing from the spirit and scope of the invention.

1. An assembly comprising: a support and drive assembly including atleast one first support and at least one second support laterally spacedrelative to said at least one first support; a first structure inoperable communication with and supported between said at least onefirst and at least one second supports of said support and driveassembly, wherein said first structure includes at least one fillingassembly and is adjustable to receive a plurality of filling assemblies;a second structure supported by said support and drive assembly, whereinsaid second structure includes at least one seal assembly that transmitsradiation to seal at least one aperture created by said at least onefilling assembly; and a drive unit in operable communication with atleast one of said first and second supports for driving said at leastone filling assembly between penetrating and non-penetrating positions.2. The assembly of claim 1, further comprising a plurality of saidfilling assembles, wherein each of said plurality of said fillingassemblies is releasably retained with at least one other of saidfilling assemblies.
 3. The assembly of claim 1, wherein said secondstructure is supported between said at least one first and at least onesecond supports of said support and drive assembly, and is adjustable toreceive a plurality of said seal assemblies.
 4. The assembly of claim 3,wherein each of said plurality of seal assemblies is releasably retainedwith at least one other of said seal assemblies.
 5. The assembly ofclaim 1, further comprising a plurality of said filling assemblies and aplurality of said seal assemblies, wherein each of said plurality offilling assemblies and each of said plurality of seal assemblies form aplurality of units that are releasably retained with each other.
 6. Theassembly of claim 1, wherein said needle filling assembly is configuredto penetrate and fill a container.
 7. The assembly of claim 5, whereinsaid plurality of filling assemblies equals said plurality of sealassemblies.
 8. The assembly of claim 1, further comprising a pluralityof said filling assemblies and a plurality of said seal assemblies,wherein said plurality of filling assemblies are arranged linearlyadjacent to one another, and said plurality of seal assemblies arearranged linearly adjacent to one another.
 9. The assembly of claim 1,wherein said filling assembly includes a filling member and a fillingmember support, and said filling member is adapted to deliver substanceinto a container.
 10. The assembly of claim 1, wherein said fillingassembly is configured to receive a cover.
 11. The assembly of claim 1,wherein said first structure is releasably retained by said support anddrive assembly.
 12. The assembly of claim 1, wherein said secondstructure is releasably retained by said support and drive assembly. 13.An assembly comprising: a support and drive assembly including a pair ofstands, said pair of stands each having a base and a support columnextending from said base, wherein each base includes a drive shaft, andeach drive shaft is in operable communication with a drive unit; a firststructure in operable communication with and supported by said supportand drive assembly, wherein said first structure includes at least onefilling assembly and is adjustable to receive a plurality of fillingassemblies; and a second structure supported by said support and driveassembly, wherein said second structure includes at least one sealassembly, is adjustable to receive a plurality of seal assemblies, andeach seal assembly transmits radiation to seal at least one aperturecreated by said at least one filling assembly; wherein said fillingassembly is in operable communication with said drive unit, and saidfirst structure and said second structure are received between said pairof stands.
 14. An assembly comprising: a support and drive assemblyincluding first means for supporting and second means for supportinglaterally spaced relative to said first means for supporting; a firststructure in operable communication with and supported between saidfirst and second means for supporting of said support and driveassembly, wherein said first structure includes at least one fillingassembly and is adjustable to receive a plurality of filling assemblies;a second structure supported by said support and drive assembly, whereinsaid second structure includes at least one seal assembly that transmitsradiation to seal at least one aperture created by said plurality offilling assemblies; third means, in operable communication with at leastone of said first and second means for supporting, for driving said atleast one filling assembly between penetrating and non-penetratingpositions; fourth means for releasably retaining said plurality offilling assemblies with each other; and fifth means for releasablyretaining said plurality of seal assemblies with each other.
 15. Theassembly of claim 14, further comprising a plurality of said fillingassemblies and a plurality of said seal assemblies, wherein each of saidplurality of filling assemblies and each of said plurality of sealassemblies are formed as one unit.
 16. The assembly of claim 14, whereinsaid first means is at least one first support, said second means is atleast one second support, said third means is a drive unit, said fourthmeans is a filling member manifold, and said fifth means is a sealmanifold.
 17. The assembly of claim 14, wherein said second structure issupported between said first and second means for supporting, and isadjustable to receive a plurality of said seal assemblies.
 18. Anassembly comprising: a support and drive assembly including a pair ofstands; a first structure in operable communication with and supportedby said support and drive assembly, wherein said first structureincludes at least one filling assembly and is adjustable to receive aplurality of filling assemblies; and a second structure supported bysaid support and drive assembly, wherein said second structure includesat least one seal assembly and is adjustable to receive a plurality ofseal assemblies, and each seal assembly transmits radiation to seal atleast one aperture created by said at least one filling assembly;wherein at least one of said stands is movable in a lateral directionrelative to the other to allow for (i) the insertion of at least one of(a) one or more additional filling assemblies and (b) one or moreadditional seal assemblies and (ii) the removal of at least one of (a)one or more filling assemblies and (b) one or more seal assemblies.